NCT05426525CompletedPhase 4
Use of Empagliflozin to Treat Prediabetes
Use of Empagliflozin to Treat Prediabetes - a Randomized, Double-blind, Placebo-controlled 13-week Intervention Trial
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Jun 2022
- Start date
- 13 Oct 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Oregon State University
- Diseases
- Obesity
- NCT number
- NCT05426525
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 13 Oct 2022 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major metabolic or cardiovascular conditions (e.g., type 1 diabetes, Crohn's disease, untreated hypo- or hyperthyroid, cancer, coronary artery disease, tachycardia, prior bariatric surgery, peripheral vascular disease, liver diseases (e.g., cirrhosis)
Other illness
- Lidocaine allergy
- Contraindications/precautions for empagliflozin (impaired renal function (EGR\<60), history of: empagliflozin hypersensitivity, ketoacidosis, hypotension, recurring urinary tract or genital mycotic infections, amputation)
Lab values
- Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
- Diagnosed type 2 diabetes. In absence of diagnosis, two separate samples with test results of fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5% (48 mmol/mol).
Other
- Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week)
- Pregnancy, planning to become pregnant or nursing
- Current or recent smoking or nicotine use (≤ 1-year abstention)
Who the study is looking for
- BMI 26-45 kg/m2
- Weight stable (± 10 lbs in previous 3 months)
- Fasting blood glucose \<126 mg/dL or HbA1c \<6.5% (\<48mmol/mol)
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oregon State University Coordinator of this site? Confirm its status | Corvallis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.